Effect of interference from hemolysis, icterus and lipemia on routine pediatric clinical chemistry assays

Agarwal, Shweta; Vargas, Germán; Nordström, C. G.; Tam, Estella; Buffone, Gregory J.; Devaraj, Sridevi

doi:10.1016/j.cca.2014.08.008

Cited by 50 publications

(41 citation statements)

References 11 publications

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“…Falsely low levels of amylase and rarely lipase are also seen in lipemic samples [23,24]. According to Agarwal study, glucose and albumin are not affected by lipemia [25]. Another study by Biljali et al showed significant differences before and after ultracentrifugation in all analytes except total bilirubin, glucose, total protein, and AST [12].…”

Section: Discussionmentioning

confidence: 99%

Lipemia Interferences in Biochemical Tests, Investigating the Efficacy of Different Removal Methods in comparison with Ultracentrifugation as the Gold Standard

Soleimani

Mohammadzadeh

Asadian

2020

Journal of Analytical Methods in Chemistry

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Introduction. As a common interferer in clinical chemistry, lipemic specimens could be a source of significant analytical errors. Ultracentrifugation has been by far the only reliable, but an unavailable and expensive, method to eliminate the lipemic effect. Materials and Methods. Among the daily samples, those with triglyceride >400 mg/dL (4.6 mmol/L) and also turbid were selected, divided into three groups, based on triglyceride concentration, and three pooled serums were made for each group. Then all pooled serums were investigated by using a DIRUI biochemistry analyzer CS-800 for routine chemistry tests in different methods including direct measurement, serum blank, serum dilution, and measurement after ultracentrifugation. Results. According to our study, there were significant differences before and after ultracentrifugation in all lipemic levels and for all parameters except for alanine aminotransferase (ALT), alkaline phosphatase (ALP), bilirubin, and uric acid. Based on allowable inaccuracy for each parameter, calcium, magnesium, phosphorus, total protein, iron, total iron-binding capacity (TIBC), urea, and chloride are being influenced by all lipemic degree and neither serum dilution nor using serum blank is as effective as ultracentrifuge for elimination. Serum blank was a proper method of lipid removal for the measurement of glucose. Conclusion. Lipemia is a well-known interferer in clinical chemistry. One cannot avoid lipemia, but fortunately, severe lipemia is a rare phenomenon in the laboratory, and for assessment of some analytes in a lower degree of lipemia, use of serum blank eliminates the need for ultracentrifuge.

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Section: Discussionmentioning

confidence: 99%

Lipemia Interferences in Biochemical Tests, Investigating the Efficacy of Different Removal Methods in comparison with Ultracentrifugation as the Gold Standard

Soleimani

Mohammadzadeh

Asadian

2020

Journal of Analytical Methods in Chemistry

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“…Hemolysis is one of the major risks during blood drawing, both in clinical studies and animal experiments [84, 85]. Although it can be avoided by careful drawing and handling of the whole-blood samples, it is the most common preanalytical error in the clinic [86].…”

Section: The Effect Of Hemolysis On the Metabolomementioning

confidence: 99%

Effects of pre-analytical processes on blood samples used in metabolomics studies

2015

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Every day, analytical and bio-analytical chemists make sustained efforts to improve the sensitivity, specificity, robustness, and reproducibility of their methods. Especially in targeted and non-targeted profiling approaches, including metabolomics analysis, these objectives are not easy to achieve; however, robust and reproducible measurements and low coefficients of variation (CV) are crucial for successful metabolomics approaches. Nevertheless, all efforts from the analysts are in vain if the sample quality is poor, i.e. if preanalytical errors are made by the partner during sample collection. Preanalytical risks and errors are more common than expected, even when standard operating procedures (SOP) are used. This risk is particularly high in clinical studies, and poor sample quality may heavily bias the CV of the final analytical results, leading to disappointing outcomes of the study and consequently, although unjustified, to critical questions about the analytical performance of the approach from the partner who provided the samples. This review focuses on the preanalytical phase of liquid chromatography–mass spectrometry-driven metabolomics analysis of body fluids. Several important preanalytical factors that may seriously affect the profile of the investigated metabolome in body fluids, including factors before sample collection, blood drawing, subsequent handling of the whole blood (transportation), processing of plasma and serum, and inadequate conditions for sample storage, will be discussed. In addition, a detailed description of latent effects on the stability of the blood metabolome and a suggestion for a practical procedure to circumvent risks in the preanalytical phase will be given.Graphical AbstractThe procedures and potential problems in preanalytical aspects of metabolomics studies using blood samples. Bias in the preanalytical phase may lead to unwanted results in the subsequential studies

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“…Importantly, at this threshold of cell-free hemoglobin, the serum concentration of ALT is also 1.65 the URL, a value that may alert clinicians about potential hepatocellular toxicity of the drug under investigation (Figure 2). In an additional study (15), the values of bilirubin and LDH and were found to increase above the 3× URL at a cell-free hemoglobin concentration of 3.0 and 6.0 g/L, respectively (Figure 2). These are two hemolysis thresholds that can also be occasionally observed in hemolyzed samples referred for laboratory testing.…”

Section: Inappropriate Sample Collection In Clinical Trials: Clinicalmentioning

confidence: 99%

Standardizing in vitro diagnostics tasks in clinical trials: a call for action

Lippi¹,

Šimundić²,

Rodríguez‐Mañas³

et al. 2016

Ann. Transl. Med.

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Translational research is defined as the process of applying ideas, insights and discoveries generated through basic scientific inquiry to treatment or prevention of human diseases. Although precise information is lacking, several lines of evidence attest that up to 95% early-phase studies may not translate into tangible outcomes for improving clinical management. Major theoretical hurdles exist in the translational process, but is it also undeniable that many studies may have failed for practical reasons, such as the use of inappropriate diagnostic testing for evaluating efficacy, effectiveness or safety of a given medical intervention, or poor quality in laboratory testing. This can generate biased test results and result in misconceptions during data interpretation, eventually leading to no clinical benefit, possible harm, and a waste of valuable resources. From a genuine economic perspective, it can be estimated that over 10 million euros of funding may be lost each year in clinical trials in the European Union due to preanalytical and analytical problems. These are mostly attributions to the heterogeneity of current guidelines and recommendations for the testing process, to the poor evidence base for basic preanalytical, analytical and post-analytical requirements in clinical trials, and to the failure to thoughtfully integrate the perspectives of clinicians, patients, nurses and diagnostic companies in laboratory best practices. The most rational means for filling the gap between what we know and what we practice in clinical trials cannot discount the development of multidisciplinary teams including research scientists, clinicians, nurses, patients associations and representative of in vitro diagnostic (IVD) companies, who should actively interplay and collaborate with laboratory professionals to adapt and disseminate evidence-based recommendations about biospecimen collection and management into the research settings, from preclinical to phase III studies.

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Effect of interference from hemolysis, icterus and lipemia on routine pediatric clinical chemistry assays

Cited by 50 publications

References 11 publications

Lipemia Interferences in Biochemical Tests, Investigating the Efficacy of Different Removal Methods in comparison with Ultracentrifugation as the Gold Standard

Lipemia Interferences in Biochemical Tests, Investigating the Efficacy of Different Removal Methods in comparison with Ultracentrifugation as the Gold Standard

Effects of pre-analytical processes on blood samples used in metabolomics studies

Standardizing in vitro diagnostics tasks in clinical trials: a call for action

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